- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study oversight and execution.Ensure their direct reports are maintaining a state of inspection readiness across all activities on their study and making sure ... measures in place to course correct where needed. The Director will be accountable to support SDL and employee...reports are properly trained, following process and SOPs. The Director will ensure the Senior Director , Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …into an annual Quality Plan, including quality risk assessments and inspection readiness components for designated programs.Ensure proactive representation of ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...during inspections and external audits. Ensure ongoing submission and inspection readiness for the respective Medical Affairs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sites. In addition, this role will support Compliance initiatives, such as inspection readiness , metrics implementation and review, overall regulatory compliance ... landscape to stay informed of regulatory trends and developmentsAssist with inspection readiness efforts and program implementation across all sites.Manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual will be the main ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE)...a global and regional level as required.Support audit and inspection readiness activities as a subject matter… more
- Merck & Co. (Rahway, NJ)
- …compliance and operational excellence in the laboratories. Maintains a state of inspection readiness . Performs proactive resourcing planning and risk assessment ... Communication, Decision Making, Dosage Forms, GMP Compliance, Immunochemistry, Innovation, Inspection Readiness , Learning New Concepts, Manufacturing, Microbiological… more
- Merck & Co. (Rahway, NJ)
- …and execution of design verification strategies, and design transfers for testing readiness , which includes incoming and release tests for components and combination ... employees at all levels to effectively engage and coordinate the implementation/ readiness and execution of design verification tests and methodologies in support of… more
- Merck & Co. (Rahway, NJ)
- …FDA Compliance, FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection Readiness , Pharmaceutical Development, Pharmaceutical IndustryPreferred Skills: ... Job DescriptionDirector - Global Quality Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Director of Inspection Readiness is responsible for ensuring ... cell therapy, and medical device operations. Reporting to the Senior Director of Inspection Readiness , this individual contributor role leverages extensive… more
- J&J Family of Companies (Raritan, NJ)
- …and Enterprise Quality (EQ) core compliance programs for Regulatory Standards Management, Inspection Support and JJT-TS Inspection Readiness . The position ... of risk themes to drive systemic actions when appropriate. This position owns the Inspection Readiness program for JJT-TS, including Data Center Inspection … more
- Merck (Rahway, NJ)
- …and operational excellence in the laboratories. + Maintains a state of inspection readiness . + Performs proactive resourcing planning and risk assessment ... Communication, Decision Making, Dosage Forms, GMP Compliance, Immunochemistry, Innovation, Inspection Readiness , Learning New Concepts, Manufacturing, Microbiological… more
- Taiho Oncology (Princeton, NJ)
- …Deviations, Corrective Actions and Preventive Actions (CAPAs). + Responsible for supporting inspection readiness related to GVP. + Support Taiho Global GXP ... Pharmaceuticals Co., Japan, TCAN. TPOC, and TPAC as needed. + Support inspection readiness activities including audits and inspections conducted by external… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …activities, in partnership with risk program and SMEs. + Support the overall inspection readiness of the GVP Audit program, including preparation for and ... Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within… more
- Bristol Myers Squibb (Madison, NJ)
- …manage regulatory inspections, applying principles of Quality Risk Management to ensure inspection readiness and compliance. Assist in the review and preparation ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Cell Therapy Quality Compliance, is responsible for ensuring robust… more
- Merck (Rahway, NJ)
- …FDA Compliance, FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection Readiness , Pharmaceutical Development, Pharmaceutical Industry **Preferred ... **Job Description** ** Director - Global Quality Auditing and Supplier Management** The Director will report to the Animal Health Global Quality Lead for… more
- J&J Family of Companies (Titusville, NJ)
- …leadership and at governance meetings (eg TA governance, DC/IC). + Lead and ensure inspection readiness for program through risk identification and readiness ... more at https://www.jnj.com/innovative-medicine **We are searching for the best talent for Director , Program Delivery Leader - Post Approval Delivery Unit, to be… more
- Bristol Myers Squibb (Madison, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director of Cell Therapy Quality Automation Services will report to the ... Executive Director of Cell Therapy Global Product Quality and serve...highest standards of cGMP compliance, product quality, and regulatory readiness as BMS automates Cell Therapy manufacturing, testing and… more
- Sysco (Rahway, NJ)
- …a high-performing quality culture across the organization. **POSITION PURPOSE:** The Director of Global Quality Assurance & Quality Control leads the quality ... systems, CAPA processes, risk management programs, change controls, and audit readiness frameworks. Lead internal and external audit programs and ensure … more
- System One (Basking Ridge, NJ)
- …Expert (SME) for safety surveillance and risk management for assigned product(s), through inspection readiness preparation, and may serve as the primary or ... Job Title : Associate Director , Clinical Safety Scientist (Contingent Worker) Job Schedule: Candidate can work 100% remote - preference would be EST/CST based… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** **Executive Director , Combination Product Development** **Overview** The Executive Director ... + Provide strategic oversight for late-stage development and commercialization readiness , ensuring robust risk-based decision-making and alignment with global launch… more
- Merck (Rahway, NJ)
- …and execution of design verification strategies, and design transfers for testing readiness , which includes incoming and release tests for components and combination ... employees at all levels to effectively engage and coordinate the implementation/ readiness and execution of design verification tests and methodologies in support of… more
